New nucleic acid test to screen donated blood for HIV-1 Group M RNA approved

Health Canada has approved a new nucleic acid test from Roche Diagnostics to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests.

"Roche is committed to meeting the needs of blood centers with tests and systems that ensure the highest blood safety," said Christopher Parker, President and General Manager of Roche Diagnostics in Canada. "Our multiplex test has been widely adopted and has demonstrated excellent performance in blood centers worldwide. We are pleased to introduce it in Canada as part of our continued investment in solutions for our critically important blood operators."

The test runs on the fully automated, real-time PCR cobas s 201 system, designed to increase processing efficiency with a unique modular design and ready to use reagents.

"By implementing this new technology, Héma-Québec will optimize its operation procedures to provide safe blood components in an efficient manner to meet the needs of Quebec residents," said Dr Francine Décary, President and Chief Executive Officer of Héma-Québec.

"The Roche MPX test raises the blood industry to a higher level with regards to overall blood safety, process simplification and process control," said Dr Graham D. Sher, Chief Executive Officer of Canadian Blood Services. "Our organization looks forward to using the MPX test."